Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000476538
Ethics application status
Approved
Date submitted
14/11/2006
Date registered
15/11/2006
Date last updated
30/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a multimedia mobile phone programme help young people stop smoking?
Scientific title
A randomised controlled trial to determine if a multimedia mobile phone programme can help young people to stop smoking
Secondary ID [1] 273501 0
Whittaker
Universal Trial Number (UTN)
Trial acronym
STUB IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation in young people 1452 0
Condition category
Condition code
Mental Health 1547 1547 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial in young smokers who wish to quit. The intervention group will receive an intensive multimedia smoking cessation programme delivered via mobile phone (such as daily video clips, SMS of quitting tips). The duration of both programmes is 6 months.
Intervention code [1] 1443 0
Behaviour
Comparator / control treatment
The control group will receive a less intensive (e.g. weekly) study-related multimedia programme delivered via mobile phone.
Control group
Active

Outcomes
Primary outcome [1] 2139 0
Continuous abstinence
Timepoint [1] 2139 0
At 6 months only.
Secondary outcome [1] 3705 0
Point prevalence abstinence
Timepoint [1] 3705 0
at 4wks, 12 wks and 6 mths.
Secondary outcome [2] 3706 0
Cost per quitter and satisfaction with programme
Timepoint [2] 3706 0
at 6 mths.

Eligibility
Key inclusion criteria
Resident in Auckland New Zealand, current smokers wanting to quit.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-smokers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
dynamic random allocation with stratified minimisation by age, ethnic group, level of dependence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Research staff (assessors) blinded to allocation
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1300
Accrual to date
Final
Recruitment outside Australia
Country [1] 417 0
New Zealand
State/province [1] 417 0
Auckland

Funding & Sponsors
Funding source category [1] 1689 0
Government body
Name [1] 1689 0
Health Research Council of New Zealand
Country [1] 1689 0
New Zealand
Primary sponsor type
University
Name
Clinical Trials Research Unit, University of Auckland
Address
Morrin & Mertons Rds, Glen Innes, Private Bag 92019, Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 1490 0
None
Name [1] 1490 0
n/a
Address [1] 1490 0
Country [1] 1490 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3138 0
Northern X Regional Ethics Committee
Ethics committee address [1] 3138 0
Ethics committee country [1] 3138 0
New Zealand
Date submitted for ethics approval [1] 3138 0
Approval date [1] 3138 0
04/10/2006
Ethics approval number [1] 3138 0
NTX/06/10/130

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27377 0
Address 27377 0
Country 27377 0
Phone 27377 0
Fax 27377 0
Email 27377 0
Contact person for public queries
Name 10632 0
Robyn Whittaker
Address 10632 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
Country 10632 0
New Zealand
Phone 10632 0
+64 9 3737599
Fax 10632 0
+64 9 3731710
Email 10632 0
[email protected]
Contact person for scientific queries
Name 1560 0
Robyn Whittaker
Address 1560 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
Country 1560 0
New Zealand
Phone 1560 0
+64 9 3737599
Fax 1560 0
+64 9 3731710
Email 1560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.